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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 February 2016 to 10 March 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Test material form:
- other: yellow semi-solid
- Specific details on test material used for the study:
- - Physical state: Yellow semi-solid
- Analytical purity:100%
- Expiration date of the lot/batch: 23 November 2017
- Storage condition of test material: room temperature in the dark
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- ANIMALS and ANIMAL HUSBANDRY
- Female Wistar rats were supplied by Envigo RMS UK Ltd, Oxon, UK.
- The animals were randomly allocated to cages on receipt.
- Females were nulliparous and non-pregnant.
- After an acclimatisation period of at least 5 days the animals were selected at random and given a unique number within the study by indelible ink-marking on the tail and the number was written on a cage card.
- At the start of the study the animals were 8 to 12 weeks of age.
- Body weight did not exceed ± 20 % of the mean body weight for each sex.
- Animals were housed individually during 24-hour exposure period and in groups of five, by sex, for the remainder of the study in suspended solid-floor polypropylene cages furnished with woodflakes.
- Free access to mains drinking water and food (2014C Teklad Global Rodent diet supplied by Envigo Research UK Ltd, Oxon, UK) was allowed throughout the study.
- Diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that would reasonably be expected to affect purpose or integrity of the study.
- Temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70 % respectively.
- Rate of air exchange was at least 15 changes per hour.
- Lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.
- Animals were provided with environmental enrichment items considered not to contain any contaminant at a level that might affect the purpose or integrity of the study.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- PROCEDURE
- On the day before treatment, the back and flanks of each animal were clipped free of hair.
- Using available information on the toxicity of the test item, a group of five male and five female rats was treated with the test item at a dose level of 2000 mg/kg
- The appropriate amount of test item was applied as evenly as possible to an area of shorn skin (approximately 10 % of the total body surface area) using a graduated syringe.
- A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage.
- The animals were caged individually for the 24-hour exposure period.
- Shortly after dosing the dressings were examined to ensure they were securely in place.
- After the 24 hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with arachis oil BP to remove any residual test item.
- The animals were returned to group housing for the remainder of the test period. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- TEST ITEM PREPARATION
- The test item was weighed out according to each animal’s individual body weight.
- Absorption of the test item was not determined. - Statistics:
- - Data evaluations included the relationship, if any, between exposure of the animal to the test item and the incidence and severity of all abnormalities including behavioural and clinical observations, gross lesions, body weight changes, mortality and other toxicological effects.
- Using the mortality data obtained, and estimate of the acute dermal median lethal dose (LD50) of the test item was made.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- - There were no deaths
- Clinical signs:
- - No signs of systemic toxicity were noted during the observation period (see Appendix 1, attached).
- Body weight:
- - Individual body weights and body weight changes are shown in Appendix 4 (attached).
- All animals showed expected gains in body weight over the observation period. - Gross pathology:
- - Individual necropsy findings are given in Appendix 5 (attached).
- No abnormalities were noted at necropsy. - Other findings:
- DERMAL REACTIONS
- Individual dermal reactions are shown in Appendix 2 and 3 (attached).
- Very slight to well-defined erythema and very slight edema were noted at the test sites of one male and all females.
- Very slight erythema, with or without very slight edema was noted at the test sites of four males.
- Crust formation was noted at the test sites of all animals.
- Small superficial scattered scabs were noted at the test sites of two females with desquamation also noted at the test sites of two females.
- Treated skin sites of males appeared normal 7 days after dosing and the treated skin sites of four females appeared normal 7 or 14 days after treatment.
- Small superficial scattered scabs were still present at the treatment site of one female at the end of the observation period on Day 14.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- EU
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.
- Executive summary:
INTRODUCTION
The study was performed to assess the acute dermal toxicity of the test item in the Wistar strain rat.
METHODS
A group of then animals (five males and five females) was given a single, 24-hour, semi-occluded dermal application of the test item to intact skin at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
RESULTS
Mortality: There were no deaths.
Clinical observations: There were no signs of systemic toxicity.
Dermal irritation: Signs of dermal irritation noted were very slight to well-defined erythema, very slight edema, crust formation, desquamation and small superficial scattered scabs. Treated skin sites of males appeared normal 7 days after dosing and the treated skin sites of four females appeared normal 7 or 14 days after treatment. Small superficial scattered scabs were still present at the treatment site of one female at the end of the observation period on Day 14.
Body weight: All animals showed expected gains in body weight.
Necropsy: No abnormalities were noted a necropsy.
CONCLUSION
The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.
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